CDC Press Conference on laboratory quality and safety after recent lab incidents

Press Briefing Transcript

Friday, July 11, 2014 11:30 a.m. ET

KATHERINE LYON DANIEL: Good morning. I’m Associate Director for Communication at CDC. Welcome to our guests in the room, to those watching on IPTV, on satellite. Today’s briefing from CDC highlights steps to improve laboratory safety after several recent laboratory incidents. We will hear from CDC Director Tom Frieden. There will be time for Q&A following his opening remarks. And a reminder that there will be a transcript available following the briefing. Questions can be directed to 404-639-3286, or they can be e-mailed to Thank you. Dr. Frieden?

TOM FRIEDEN: Good morning, everyone. Thanks for joining us today. And I will say that we have a lot to cover. But there’s going to be time to answer questions. I’d like to really outline what has happened in recent months, give the details, give what happened, why it happened and what we are doing about it. In the world of infectious diseases, being busy is not good. And lately, we’ve been very busy. Whether it’s MERS in Saudi Arabia where we’re helping to contain the outbreak, or Ebola in West Africa where we have teams helping to stop the outbreak there or the emergence of a new mosquito-caused disease, a mosquito-carried disease, Chikungunya, in the hemisphere, we’re helping countries to respond. CDC is active all over the world. But there’s more that we’re doing around the world. However, today what I want to talk about are three laboratory incidents that raise serious and troubling questions.

First, we had the potential exposure to anthrax at CDC’s laboratory. Second, earlier this week, we learned about an incident in CDC’s influenza laboratory. And third, we had the discovery of vials labeled as smallpox in a storage room on the NIH campus and CDC’s work to secure and to characterize these materials. I’ll give you the facts about each of these three incidents and for the two that happened here at CDC, what we’re going to do to address these incidents because fundamentally, what they reveal was totally unacceptable behavior. Before I discuss the details, I’ll give you my perspective which is plain and simple. These events should never have happened. Together, these events I’m sure have many people asking and questioning government labs. They may be wondering whether we’re doing what we need to do to keep our workers and our communities safe. And I think it’s fair to raise those questions. I’m disappointed by what happened, and frankly, I’m angry about it.

The American people depend on us 24/7 to protect them. Our scientists go anywhere in the world at a moment’s notice to stop an outbreak. And just as the American people depend on CDC to protect their health, our workers should be able to depend on us to protect their health. And Americans should know that we’re implementing the highest levels of safety and security in our laboratories and throughout our work. Our labs, our lab scientists are a national treasure. We are essentially the reference laboratory for the world. So when something like this happens here, I’m deeply concerned about it. These events should never happen. And if you remember nothing else from what I say this morning, I want you to remember three things.

First, I’ve issued a moratorium on CDC transferring any biological samples out of any BSL-3 or BSL-4 laboratory either within CDC or outside of CDC until we have given a lab-by-lab assessment and allow that process to resume. Second, I’m appointing a single point of accountability, Dr. Michael Bell, who’s with us this morning, to be Director of Laboratory Safety for CDC and to oversee implementation of the recommendations that I’ll be talking to you about later and to report directly to me. And third, I’ve directed that appropriate disciplinary action be taken for any staff member at CDC who knowingly violated protocols or who failed to appropriately report a lab incident. Now I’d like to describe each of the three incidents in more detail, and we can provide additional detail in the question/answer if you’d like. Each of the incidents is complicated, so please bear with me because I want to be sure to give you all of the information that we’re aware of up to this moment.

First is the potential exposure to anthrax. Today, we’re releasing the results, in fact, our full internal investigation of that incident as well as the steps we’re taking that will do everything humanly possible to make sure that nothing like that happens again. On June 5th of this year, a laboratory scientist working in one of our bioterrorism response laboratories made a mistake. They used a process that they thought would kill the anthrax bacteria, and it may not have. We’ve looked carefully at the factors that led to that mistake. But because of that, workers in other laboratories who received materials that that laboratory prepared may have been exposed to anthrax. While we’ve assessed the event, we’ve learned more about what happened. I can later go into some details about this, but as I think about it, what we learned made us more reassured about the likelihood that people were actually exposed, which now looks very, very unlikely. But more concerned about the policies and procedures that allowed this event to occur in the first place.

So just to give a little bit more details, what happened was that the process to inactivate the anthrax spores was not appropriate. And it was not done as it was supposed to have been done. So there is the possibility that some spores were transferred to other laboratories within CDC and potentially exposed other workers. We did additional experiments to replicate in a worst-case scenario what might have happened in that process. And those experiments which we did and a partner laboratory, the Michigan Department of Community Health did, suggested that for one form of anthrax, the form that grows, this procedure certainly killed all of the organisms. For another form of anthrax growing, what are called spores, which are quite resistant to being killed, there is the possibility, although unlikely, that some got out. The way that experiment was used was basically a worst-case scenario experiment. If you had a huge concentration of spores and you followed the procedure that was used, would any of them survive? And out of a huge number put in, there was a tiny amount of growth found. What that tells us was that it was not impossible that some spores were transferred, but it was extremely unlikely. Now, that doesn’t excuse in any way what happened or minimize it.

We’re very concerned about the health and well-being of our own staff. And the fact that they had to deal with uncertainty, stress, potential risk and to take preventive medicines that can have adverse events as a result of this incident is something that I feel terrible about, and I wish had not happened. The report we’re releasing today, though, looks at the root cause of this incident. And the root cause fundamentally was that the scientists failed to follow a scientifically derived and reviewed protocol that would have assured that anthrax was inactivated and that the material was confirmed to be sterile before it ever left the lab. That should have happened, and it didn’t.

There were multiple other problems found, a lack of standard operating procedures, a lack of lab – adequate laboratory oversight, a lack of an approved study plan, use of unapproved sterilization techniques for anthrax, the transfer of material that wasn’t confirmed to be inactive. In fact, the use of anthrax at all for this experiment should not have been done. It was not appropriate. And there was a lack of scientific knowledge in this laboratory about inactivation because there were articles in the published literature that indicated that this was not a perfect method to inactivate anthrax. This laboratory is closed, and it will remain closed with respect to what we call select agents which are the most dangerous microbes until it is completely reviewed and until Dr. Mike Bell and his group recommends to me and I approve its reopening under different conditions that we’ll do everything humanly possible to assure that nothing like this happens again.

That brings me to the second incident relating to influenza. And for me personally, this is the most distressing of the three incidents for two reasons. First, because it happened in our influenza laboratory. And second, because it happened six weeks ago, and I learned about it less than 48 hours ago. On Wednesday of this week, we learned of another event at CDC. Our influenza laboratory was preparing a less harmful strain of animal influenza for shipment to a partner laboratory. In the process, unknowingly, they cross-contaminated that strain with highly pathogenic H5N1 influenza. As a result when they sent it to the U.S. Department of Agriculture laboratory to see for the research that they were doing on the low pathogenic, the relatively safe influenza strain, that laboratory saw that it was not behaving as a low pathogenic strain would behave. And they therefore did tests and identified on May 23rd or thereabouts that it was contaminated with H5N1. They informed the CDC laboratory staff, the CDC laboratory staff did testing to confirm that, in fact, it was the specimen we sent there that was contaminated and that when we got the strain into our laboratory, it wasn’t contaminated, so it happened here.

We’re still just beginning the investigation to determine how this happened. The work was done in one room. So that leads to some early hypotheses of what might have happened. But it’s going to take a detailed investigation. And we may not know for certain exactly what happened, but we’ll do everything we can to find out. Now, on July 7th, that’s when — earlier this week — six weeks after it should have been reported, the incident was reported to senior leadership. I want to make clear in this incident, all of the materials were handled in what’s called enhanced biosafety level 3 facilities. That means people shower out. That means they wear highly protective form of personal respiration, and we have a high degree of confidence that no one at CDC was exposed and that there was no release of these samples. So they’re really events that serve as a warning that the protocols are not what they need to be to ensure that our laboratories operate safely.

So as I’ve said, I’ve taken a series of steps in response to these incidents. The first is the moratorium on biological material leaving BSL-3 and BSL-4 laboratories, and we will assess laboratory by laboratory before reopening. The second is that we will — I’ve appointed Dr. Michael Bell to be Director of Laboratory Safety and serve as the single point of accountability to improve all laboratory safety protocols and practices and procedures. And I’ve established a high-level working group chaired by Dr. Bell that will report to me to accelerate improvements in laboratory safety and serve as the transition group for permanent single point of accountability on laboratory safety which is something called for in the review of the potential exposure to anthrax incident. The culture of laboratory safety needs to improve at some CDC laboratories.

Third, the general issue of inactivation, how do you kill bacteria or viruses before you transfer them out, that procedure will be looked at every laboratory that works on not just select agents but any dangerous pathogen at CDC, and if needed, we will improve it. Fourth, I’ve begun the process of establishing an external advisory group that will be part of the advisory committee to the director, and I will issue invitations to the leading scientists of that group by the end of next week. Fifth, I’ve ordered an investigation to determine the root causes that led to contamination of H5N1 in the influenza laboratory. Sixth, I’ve reported the incident through the proper channels — or CDC has reported the incident through the proper channels to the select agent oversight body, the agriculture department’s inspection service which is known as APHIS. We’ve established a review group under the direction of the Associate Director for Science to look at procedures leading to these events and ways to prevent them in the future. This review will be done in conjunction with the internal investigation and in coordination with the external working group.

Eighth, our response to future incidents will be improved by rapidly using incident management systems such as the one that we use for external events. We’ll use that for certainly events when we need to. Ninth, as I mentioned, I’m requiring that disciplinary action be taken as appropriate for any staff member who knowingly departed from lab safety protocols or who knew about lab safety incidents and didn’t report them promptly. And tenth, we’re looking at the implications for select agents and virulent pathogens more broadly, not just within CDC but throughout the scientific community including in our regulatory function at CDC where we have a unit called the Division of Select Agents and Toxins. Given the critical nature of our investigations, the work that we do here to protect Americans, it’s crucial that we do this safely and that we protect our staff while we do it. I will personally track the implementation of these plans.

Third and finally, I’d like to discuss some breaking news with the vials of smallpox found on the campus of the NIH in Maryland. NIH moved swiftly to make sure that the specimens were secure and expert staff at CDC along with federal partners quickly secured and retrieved the specimens and transported them earlier this week here in Atlanta. There was no risk to workers or to the public, but this event also should never have happened. My understanding is that NIH will scour their entire campus to see if there are any other stray materials that shouldn’t be present, and CDC, which has a regulatory function in this area, will monitor their progress and completion in doing this. CDC scientists worked rapidly to analyze the contents of the six vials labeled as variola, the smallpox virus. First they did what’s called PCR, a chain reaction to see if there was DNA from smallpox there. And yes, in fact, there was. That told us that smallpox had had been present in those vials, but it didn’t tell us if it was what we call viable, or alive. That requires putting it into a tissue culture and seeing if it grows, then repeating that test to see if the number of organisms is increasing.

On Monday night, they worked through the night to confirm that the DNA was present by PCR testing, they then injected the material into special materials to see if it was alive. And yesterday we learned that two of the six vials showed evidence of growth. Our scientists again repeated the PCR testing and determined that the growth is indeed smallpox virus. This is growing in our approved smallpox containment laboratory, a BSL-4 facility. We’ve already begun the process of analyzing the entire genetic sequence of the smallpox virus, and we’ll see whether any of the remaining four vials grow. Something that may take up to two weeks. After we’ve monitored growth and sequenced the genome, we will destroy the vials and all of the culture material from these materials. That’s what should have been done a couple of decades ago, and that’s what will be done now, and we’ve invited representatives from the World Health Organization will witness that destruction. Whoever created these vials didn’t do so out of malice. In fact, they come with the date of February 10th of 1954. That’s when they were created. That was before smallpox eradication. In fact, that’s before smallpox eradication was undertaken.

The problem was not in the creation of the materials but in the inventory control which allowed them to remain unsecured for decades. They should have been destroyed decades ago, and once we complete the work here, we will destroy them. I’ll end today’s briefing by reiterating an important point I started with. The American people depend on CDC to work 24/7 to protect their health. They also expect us to adhere to the highest standards possible. And I expect that as well. Because our scientists and our laboratories are national treasures, all of us at CDC share a responsibility to make sure that we do everything possible to make sure our staff are safe when they do their work. That’s why events like this should never happen, and that’s why I will do everything in my power to make sure that nothing like this happens again. Thank you very much. And I’ll be happy to answer questions. We’ve got a lot of people on the phone. So we’ll be going back and forth between the phone and the room.

JOHN ROBERTS: Yes, Dr. Frieden, your report details that there was a similar incident involving the bioterror rapid response lab and anthrax in 2006. My question is what were the security protocols that were put in place following that? And were those protocols followed? You’d think if you had a similar incident in 2006, you wouldn’t be in the position that you find yourself in today.

TOM FRIEDEN: Our report outlines all prior incidents that we’re currently aware of dangerous pathogens leaving a CDC lab when they shouldn’t have left a CDC laboratory. One of those incidents was in 2006 from the same laboratory that was involved in the anthrax work that we described now. My understanding is that the staff were not the same staff at that time. But after the 2006 episode, what they did was implement a procedure for one particular type of specimen. If they had used that particular procedure for this type of specimen, then it would not have happened. So the procedure that they put in place in 2006 was appropriate, but they didn’t go deep enough in terms of outlining, all right, how do we make sure if this had happened, that we don’t just prevent this but everything like this from happening in that laboratory. Let’s go to the phone.

OPERATOR: On the phone lines if you’d like to ask a question, just press star-1 at this time. And we do have a question from Miriam Falco with CNN. You may ask your question.

MIRIAM FALCO: Hi, Dr. Frieden. Thank you for taking these questions. So much you’ve covered, I’ll ask you one question. Why did it take so long for the second incident that you’ve described to be revealed? And how many lab folks at CDC employees are being tested or are concerned about possible exposure to this H5N1 mixed with a more easily transmissible flu, I presume?

TOM FRIEDEN: At this point everything we’ve looked at strongly suggests that there was no exposure of anyone to influenza in the second incident that I described. The people who were involved were wearing what are called “PAPRs” or positive air pressure respirators. They were working in an enhanced BSL-3 facilities. So multiple redundant checks to prevent infection with flu. So we do not think there was a human exposure there. As to why it took six weeks for that to be made apparent to us, I can think of no valid explanation. Next question on the phone.

OPERATOR: Thank you. Next question comes from Mike Stobbe with the Associated Press. You may ask your question.

MIKE STOBBE: Thank you. So many questions I’d like to ask. If I could start, doctor, you said that the flu incident was the most distressing. Do you mind clarifying why and also addressing — did the sample end up mutating or changing as a result of — is there some ongoing concern regarding the results of that cross-contamination?

TOM FRIEDEN: Thank you. I’m really glad you asked that. It’s most distressing not because it’s most dangerous. Everything we know today suggests there was no human exposure. The materials are all either destroyed or contained, and there’s no risk from it. What’s distressing about it are two things, really. First, our influenza laboratory is a superb laboratory. We have wonderful laboratory scientists in that laboratory and throughout CDC. So to me, the fact that something like this could happen in such a superb laboratory is unsettling because it tells me that we need to look at our culture of safety throughout all of our laboratories. Second is deeply troubling that there was what is an unacceptable delay in providing this information. It’s very important to have a culture of safety that says if you’ve got a problem, talk about it. The biggest way to get into more trouble is not to talk about something when you’ve got a problem. So that kind of delay is very troubling. And I know it’s very troubling to the people who oversee that unit as well and very unexpected. So we will do a full investigation to understand the causes of it. Again, we just learned about it within the last couple of days. We’re confident of the containment, but the causes of it and the actions that we’ll take as response are going to take some time.

MIKE STOBBE: And could you say how many BSL-3 and -4 labs there are, and are they all in Atlanta, or where are they?

TOM FRIEDEN: CDC has many biocontainment laboratories. How you count them depends on whether you’re talking about rooms or investigators. We have laboratories here at the Atlanta campus at Roybal, we have one BSL-3 laboratory over at the Chamblee campus, we have BSL-3 laboratories out in Fort Collins, Colorado, our vector-born program. And in case of backup, we’re authorized to work in one of our Alaska laboratories that we don’t have contained specimens there, but that’s a backup redundant facility. Next question on the phone.

OPERATOR: Thank you. Next question comes from Lena Sun with the Washington Post. Go ahead with your question.

LENA SUN: Hi, Dr. Frieden. I guess my question is the report actually details four other incidents in addition to the last month’s anthrax release. I know that you’ve said this, but each team there was, I guess, incident, why were there — how could this have happened at the CDC that all these agents were released in the last decade?

TOM FRIEDEN: I asked the same question. And it’s a totally valid question. I think people have had a narrow vision of the problem. There’s a problem, they fixed that problem. What the events of the past couple of months have told me is that there’s a problem, and it’s a symptom of a broader problem of laboratory safety. And we need to stop, reassess, fix and make sure that we do everything humanly possible to make sure that events like this never happen in the future.

LENA SUN: Do you know whether these — in the previous incidents when those — aside from the flu one, the other three incidents, what happened to those organisms and whether there were any exposures?

TOM FRIEDEN: In the other incidents, from everything I understand there were no exposures, and the organisms have been completely contained. So there was no release. These are procedures in laboratory procedures. If I could talk for a minute about how to improve performance. It’s very important that people understand that mistakes are human. That’s why we put in systems so that if human mistakes occur, human harm will not occur. That’s what redundant systems are about. And that’s why it’s important the staff feel comfortable coming forward if there’s a problem. That’s why it’s important that we have protocols in place that are rigorously reviewed. One of the things that may happen — and this is just a hypothesis — is that when most people hear about anthrax or another deadly organism, they think, you know, this is something that is, of course, terrifying, and it is. But if you work with that organism day in and day out for days, weeks, months and years, you can get a little careless. And that’s something that may have happened. And that’s why Dr. Bell is going to look at every way we can to enhance the culture of safety so we have — we’re not relying on people to do the right thing, though we want them to do that, we’re relying on systems so that even if someone makes a mistake, there will not be a risk to people. I’m going to go to people who haven’t asked questions yet. More questions on the phone?

OPERATOR: Thank you. Next question comes from Nancy Snyderman with NBC News.

NANCY SNYDERMAN: Dr. Frieden, you just alluded to sloppiness. Is there any common denominator as you look at this early as to whether your protocols for safety are antiquated or whether these are junior lab people who have — don’t have experience, or to the contrary, senior people who have just become lax after years and years of being in a lab?

TOM FRIEDEN: I think if we look at laboratory science overall, there’s been a lot of change in recent decades. In fact, when I joined CDC in 1990, I did an investigation of laboratory cross-contamination in community hospitals and academic medical centers throughout New York City. And we found that about 3 percent of all cultures were cross-contaminated, which was really quite terrifying because it meant that somewhere in those laboratories, tuberculosis has been floating around. It had gone from one culture plate to another. Over the past couple of decades, we’ve implemented the Clinical Laboratory Improvement System, CLIS, and that has resulted in steady improvements in laboratory quality and safety in laboratories that test for human specimens. At CDC, we have laboratories that don’t test for human specimens, but they also need to have quality management systems in place. The issue isn’t about individuals doing the wrong thing. The issue is about systems that aren’t reliably preventing this from happening. And that’s what we will make sure to implement.

NANCY SNYDERMAN: And on a secondary note very quickly, the whole idea of keeping smallpox, keeping anthrax cultures, would you talk for a second about bioterrorism and why certain materials are kept at the CDC?

TOM FRIEDEN: We wish we didn’t have to do research like this. But the fact is that anthrax has been used as a weapon, and there’s a risk it will be used as a weapon. And that’s why we do work to make sure that we could diagnose it effectively throughout the U.S., we do research to figure out how to diagnose it more rapidly. In fact, the project that led to the potential exposure was a project to try to figure out a quicker way to diagnose anthrax with a new and interesting technology. We do research to figure out how better to treat people if they’re exposed and prevent it if they’re exposed and how better to prevent it through vaccination. The fact is that an continues to occur in nature and that anthrax has been used as a weapon. So though we wish there’s parts of the science that we work on weren’t necessary, unfortunately, in the world we live in today, they are.


JOHN ROBERTS: Everybody on the phone was asking two questions so i thought I might try to get a second one in. I just want to get a personal reaction here, Dr. Frieden. You and I have known each other for a long time. This is the Centers for Disease Control. As another caller said, this is the envy of the world. This is the preeminent infectious disease sleuthing agency. Books have been written. Movies have been made about this place saving the world. You talked about your personal reaction earlier. Let me get you to expand on that if I could. As to how you feel about this happening at this place.

TOM FRIEDEN: I will say that I’m just astonished that this could have happened here. We have such great scientists. When I joined CDC as director in 2002, one of the things that made the biggest impression on me was how wonderful our laboratories are. During H1N1 pandemic, this laboratory did phenomenal work sequencing specimens, figuring out where the virus was going. Our laboratories are core to our ability to protect Americans. Our laboratories are the reason we are the gold standard for not just infectious diseases but environmental health as well. And for this to happen and put our workers potentially at risk is totally unacceptable. So I’m upset. I’m angry. I’ve lost sleep over it, and I’m working around the clock to make sure we do everything possible to resolve it. On the phone?

OPERATOR: Thank you. Next question on the phone comes from Danny Al-Faruque with The Hill newspaper. You may ask your question.

DANNY AL-FARUQUE: Thank you very much. I have two quick questions. One, in both these cases, I wanted to understand how much — and sorry, I’m talking about the cases of the anthrax and influenza case — how much of it was just dumb luck that the spores were able to get out into the general public? And secondly, in both these cases, there seems to be a huge lag between when these events were found out and when they were reported. Is there some sort of — when you talk about culture, is there some sort of culture of fear that people who worked at the CDC were afraid to tell upper management?

TOM FRIEDEN: Well, first off, to clarify a few things, there was no delay in the anthrax exposure incident when that was — came to light, the same day I was notified, and we began our response. In the influenza episode, we will certainly try to understand what went into that delay because we think that’s very unusual behavior for CDC and not acceptable behavior. In both incidents, there is no risk that agents were released outside of CDC. In terms of the influenza work, it was all done in a highly contained environment, both here and at the USDA laboratory, and our understanding is there is no risk of it having either exposed workers or gotten out into the community, and that’s certainly the case with the anthrax episode as well. Next question on the phone.

OPERATOR: Next question comes from Eben Brown with Fox News Radio. Go ahead with your question.

EBEN BROWN: Thank you. Good afternoon, Dr. Frieden. H5N1, is this the same H5N1 that was commonly referred to as bird flu or avian flu?

TOM FRIEDEN: So there are multiple forms of avian flu, and this is one of them. There’s also the avian flu that emerged in china a few years ago. That’s a different form of avian flu. But this one has been around for about a decade, and it’s one of the ones that does concern us because it can be quite deadly both for poultry and for people.

EBEN BROWN: Thank you very much.

TOM FRIEDEN: Next question on the phone?

OPERATOR: Our next question comes from Donald McNeil from the New York Times; you may ask your question.

DONALD MCNEIL: Thank you. I may have misunderstood something you said. Are you shutting down shipments out of any non-CDC BSL-3 or BSL-4 laboratories or are you asking any other federal agencies or university labs to shut down those kinds of shipments?

TOM FRIEDEN: No, the moratorium that we are implementing applies specifically to CDC. I’ve discussed this with both NIH and FDA leadership. Their issue had to do with inventory control and both NIH and FDA are doing comprehensive work to look at inventory control in all of their laboratory facilities to see if there are any other unexpected items out there.

DONALD MCNEIL: But there’s no effort to extend it even by request to other agencies or to any private labs to make them look at their procedures before samples are shipped? I mean, this obviously is related to the gain of function work that’s going on around the country.

TOM FRIEDEN: The broader issue — and it’s in our report that we released today — the broader issue is we think there are lessons here for other laboratories. As we absorb those lessons and learn them, we will incorporate them into our regulatory function and send advice out to any laboratory working in BSL-3 or BSL-4 facilities about things like inactivation procedures. One of the things that we’ve learned in public health is in any procedure, there may be — or process — there may be certain points that are particularly high risk, critical control points. Inactivation, for example, is a critical control point within laboratory safety. And so we’ll be looking at ways to have redundant systems to affect and improve this through our work. Our first effort is to understand fully what happened and remediate it here at CDC, but we are definitely looking at the implications for laboratories around the country and around the world. On the phone?

OPERATOR: Thank you. Next question comes from Lisa Schnirring from CIDRAP News. Go ahead with your question.

LISA SCHNIRRING: Hi. Thanks so much for all the details today. I just wanted to ask specifically about your flu lab. How is that affecting surveillance in the United States over the summer? I know that it’s flu season in different parts of the world. I’m just — it’s said that the lab was closed for now until the investigation is complete. I was just wondering how that impacts the other things that you’re doing.

TOM FRIEDEN: We’re confident that we’ll be able to get the flu lab reopened in time to do the essential work it does like helping to prepare the influenza vaccination for Americans in tracking the spread of flu around the world and around the country. So at this point, we don’t see any risk to keeping the lab closed until we have a full assessment of what happened and are sure that we can prevent future occurrence. Yes?

LISA SCHNIRRING: Thank you, Dr. Frieden. I’m just curious what kind of impact the moratorium will have on the work that you’re doing, number one. And number two, you’ve talked a lot about putting new procedures in place. But how do you change the culture? I mean, this administration has been here since 2009 at the CDC. Obviously this is an ingrained culture. How does that change? What are you doing for that?

TOM FRIEDEN: In terms of the impact of the moratorium, we’re going to assess that laboratory by laboratory. We do have partners who rely on us for sending out things like proficiency panels. And we’ll just have to make sure that if any material leaves, when any material leaves, we assure that it actually needs to leave and that it leaves in a way that’s absolutely safe. For example, documenting the inactivation in a fail-safe way. In terms of laboratory culture, I believe it’s an issue that requires continuous improvement. And I don’t think it’s an issue across all CDC laboratories. We have hundreds of laboratories at CDC. And making sure that we have a culture of safety in each and every one of those is critically important. These are wake-up calls. These are events that tell us that we have a problem and we’re going to fix it. On the phone?

OPERATOR: Thank you. Next question comes from Betsy McKay with Wall Street Journal. You may ask your question.

BETSY MCKAY: Thank you. Dr. Frieden, you were talking about the need to address, you know, the problem more fundamentally rather than just the symptoms. And so I wonder if you could talk about whether you think procedures for regular inspections of labs that work with select agents need to be toughened since CDC has played a role itself in these inspections. Do you need to seek more, you know, third-party oversight? Could you just talk a little bit about that?

TOM FRIEDEN: We have undertaken a series of measures over the past few years to strengthen our investigation of select agent laboratories. We do unannounced inspections. We’re doing other things to look at critical control points. But I think absolutely, we’re going to look at this experience and these two incidents or three incidents in particular and more broadly at a culture of lab safety to see what we can do to ensure that work that’s done with either select agents or other dangerous microbes is done safely. And that’s going to require careful review of what actually happened and a careful consideration for what will be effective at improving laboratory safety around the country and around the world. I think we recognize that these are dangerous agents. And to work with them means to have a special responsibility to protect both the workers and the public. And we’ll be looking at what the implications are for our division of select agents and toxins as well as other partners.

BETSY MCKAY: Okay. Thanks.

TOM FRIEDEN: On the phone?

OPERATOR: Thank you. Next question comes from Eui Hoai-Tran with USA Today. You may ask your question.

EUI HOAI-TRAN: Hi, Dr. Frieden. In terms of the smallpox vials that were found at the NIH lab, you said you were planning to scour those labs. Are you also planning to scour any CDC labs or campuses that may have any unsecured samples or like that?

TOM FRIEDEN: We have done that. When smallpox was eradicated, there was a global agreement to identify any existing sample and to either destroy it or send it to one of two laboratories. Here at CDC or in Russia where there’s a WHO., world health organization, authorized laboratory. So all materials either should have been here in our laboratory where they’re secured or in Russia or destroyed. So the NIH and FDA are both scouring their campuses to see if there are other examples. This is something that Dr. Bell will look at in terms of our laboratory. But in terms of smallpox, we’re confident that there are not other samples anywhere at CDC. I will say that there is an analogy with polio because we’re now making progress toward polio eradication. Once polio is eradicated, and I am confident it will be, we’ll need to do something very similar with the polio virus. And fundamentally, and this is relation to the previous question from the wall street journal as well, one of the things that we want to do is reduce the number of laboratories that work with dangerous agents to the absolute minimum necessary. Reduce the number of people who have access to those laboratories to the absolute minimum necessary. Reduce the number of dangerous pathogens we work with in those laboratories. So for example, in the anthrax episode, they could have used a harmless form of what’s called bacillus, the same genus but a different species for that experiment. And also make sure that in the work that we do, we’re not risking others. So it’s a coning down and a stepping up of security within that procedure. Did you have a question? On the phone?

OPERATOR: On the phone lines again if you’d like to ask a question, just press star-1. Our next question comes from Helen Branswell with Canadian Press. You may ask your question.

HELEN BRANSWELL: Hi. Thank you very much, Dr. Frieden. I have three quick questions. The — the flu strain that your lab thought it was sending isn’t identified, but it was going to a bsl-3 lab. So what was that, please? It clearly wasn’t seasonal flu. Secondly, at the receiving end, if USDA discovered that what they had was contaminated with h5n1, was it not also incumbent on them to report the incident on May 23rd when they found out that this was going on? And third, you know, Donald made reference to the gain of function work, and this is going to explode that issue. You just talked about coming down the amount of risky work. One of the big arguments made for — in defense of gain of function work on flu was that this work is done very safely and that labs know how to do this very safely. And I’m wondering if you’re rethinking that now.

TOM FRIEDEN: For the nonpathogenic avian influenza was h7 — sorry, h9n2? H9n2, sorry. And we have a graphic that we can provide you, which describes the movement of that isolate and when it got contaminated and when it was then destroyed. In terms of the department of agriculture laboratory, you’d have to direct that question to them. And in terms of the gain of function studies, I think whatever you think about gain of function studies and dual use research of concern; I think it’s clearly the case that these incidents indicate that we need to really ensure that whatever work is done needs to be done safely and securely. Two more questions. On the phone?

OPERATOR: Thank you. Next question on the phone lines comes from Julie Steenhuysen with Reuters. You may ask your question.

JULIE STEENHUYSEN: Hi. Yes, thank you for taking my question. Dr. Frieden, you mentioned that there will be some disciplinary action taken. Do you know at this time what those actions will be? Are there specific individuals who will be demoted or losing their jobs over this? And ultimately, who is responsible for the safety of the laboratories at CDC?

TOM FRIEDEN: Well, in terms of the individual human resources and personnel actions, it will depend on the investigation. The investigation will determine what happened and recommend appropriate action for that. And that’s what I want to ensure happens. Including responsibility not only for the individuals who may have personally carried out the experiments, but for those who set up a system for them to do those experiments within. In terms of the culture of safety, while we’re appointing Dr. Bell to be the single point of accountability for laboratory safety at CDC — in fact, what we need to ensure is that safety is a laser-like focus for every single level of the organization. Every center director, every division director, every branch director, every lab director, every lab worker, and myself. Because we all share responsibility for making sure that the work we do is done safely and securely.

JULIE STEENHUYSEN: Yeah, I have just a quick follow-up. I’ve been covering this issue for a while. And some of the sources I’ve talked to have said and criticized CDC in saying that there is — there has been this reliance — almost – I don’t want to say arrogance, but extreme confidence that, you know, the way we do it at the CDC is the right way to do things. This is, you know — gives — make you reconsider or want to take a look at that idea? I mean, basically have you been arrogant? Sorry to ask it in such a blunt way.

TOM FRIEDEN: Well, I think, as I said, I think this is a wake-up call. These events should never have happened. And they tell us that we they’d to make significant improvements to ensure that our lab workers remain safe. Did we have a question in the room?

TOM FRIEDEN : Yes. One other question for Dr. Bell. There’s a mic over here, please.

DARRALL JOHNSON: Just a question for Dr. Bell. You mentioned that the delay in notification was one of your concerns. I just wanted to know what some of your concerns would be coming into this position.

MICHAEL BELL: Thank you for asking that. I think there’s some major systematic issues that we want to look at. As Dr. Frieden mentioned, this is a symptom. It’s not the little mistake that we’re concerned about in this instance. We’re concerned about what is the framework that everyone’s using? And that framework includes rapid reporting. It includes an understanding of the chain of communication and who you tell when. Add to that the fact that people need to be comfortable doing this. We can bolster that and make use of this series of events to make sure that in the future; there is much less likelihood of this happening again. The work of safety is never complete. We will continue to innovate. We’ll be continuing to have new technologies. There will be new diseases. And this is part of the work that we do in public health to maintain safety and grow with the science so that we can assure that what we do doesn’t harm anybody that’s doing the work or is nearby.

TOM FRIEDEN: On the phone?

OPERATOR: Thank you. Next question comes from Sabriya Rice with Modern Healthcare Magazine. You may ask your question.

SABRIYA RICE: Yeah, good morning. Thank you for taking my question. I wanted to ask about — you had mentioned before that, you know, that the incident that happened in 2006 was the same lab but with a different set of staff. I wanted to know, what is the training for people when a new protocol is introduced? How are staff kind of made aware of the new protocols and what they should be doing?

TOM FRIEDEN: One of the issues, which Dr. Bell and his working group will look at is exactly that. How we train staff and how we make sure that new staff are trained, that people learn from past incidents and that procedures are in place that are clear, understandable, easy to follow and that training is then assessed and repeated as necessary. I’m going to stop there. We do have the ability to answer your questions going forward. But I do want to end with just summarizing what we found. We had three incidents, two at CDC and one at NIH where CDC was able to then secure that material. But those incidents revealed to us an unacceptable set of practices at CDC. As a result of that, we’ve immediately stopped shipping any laboratory samples out of our high containment laboratories, bsl-3 or bsl-4. We’ve established a single point of accountability, and we will look at every aspect of laboratory safety with a laser focus. And we will take appropriate disciplinary action after we complete our investigation of what actually happened in these two incidents. We wish that research of this type and organisms of this type didn’t have to be studied at CDC. But given the world we live in, they continue to spread in nature and make people sick and kill them. They continue to have the potential to be used as weapons against individuals. And so we have to do this research. But we have to do it safely. Thank you very much.

OPERATOR: That concludes today’s conference. You may disconnect at this time. Thank you for your participation.


Page last reviewed: July 14, 2014